Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding (DUAO)
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|ClinicalTrials.gov Identifier: NCT00496080|
Recruitment Status : Terminated (Trial terminated early due to results from a similar study.)
First Posted : July 4, 2007
Results First Posted : July 24, 2012
Last Update Posted : September 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia Uterine Fibroids||Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
Experimental: DUAO Device
Doppler-guided uterine artery occlusion device (Single-arm study)
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)
Investigational transvaginal clamp inserted one time for 6 hours.
Other Name: floSTAT
- No Surgical Re-intervention [ Time Frame: Study completion ]Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.
- Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score [ Time Frame: From baseline to 12 months ]Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.
- Mean Improvement in Health Related Quality of Life (HRQOL) Scores [ Time Frame: From baseline to 12 months ]Participants categorized as "better" in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. "Better" was defined as a change of +12 or more from baseline at 12 mo.
- Maintenance of Menses [ Time Frame: 12 months ]Number of participants with continuation of menstrual cycles without interruption for three consecutive months
- Procedural Satisfaction [ Time Frame: 12 months ]Number of participants with responses of either "satisfied" or "very satisfied" on a qualitative survey that ranged from "very dissatisfied" (worst) to "very satisfied" (best)
- Decrease in Fibroid Bulk [ Time Frame: From baseline to 12-months ]
Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.
Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200.
- Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores [ Time Frame: From baseline to 12 months ]Number of participants categorized as "better" in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. "Better" was defined as a change of -11 or less from baseline at 12 mo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496080
|United States, Arizona|
|Women's Health Research|
|Phoenix, Arizona, United States, 85015-2110|
|United States, Florida|
|Holy Cross Medical Group|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Michigan|
|University Women's Care - Wayne State University|
|Southfield, Michigan, United States, 48034|
|United States, Minnesota|
|Minnesota Gynecology and Surgery|
|Edina, Minnesota, United States, 55435|
|United States, Missouri|
|St. Luke's Hospital|
|Chesterfield, Missouri, United States, 63017|
|United States, North Carolina|
|North Carolina Children's & Adults' Clinical Research Foundation|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Ohio|
|Complete Healthcare for Women|
|Columbus, Ohio, United States, 43231|
|United States, Pennsylvania|
|Hahnemann University Hospital - Drexel University School of Med.|
|Philadelphia, Pennsylvania, United States, 19102|
|United States, Texas|
|Arlington, Texas, United States, 76014|
|St. Joseph's Health Care|
|London, Ontario, Canada, N6A 4V2|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Study Director:||Piet Hinoul, M.D.||Ethicon, Inc.|